NCT06899230

Safety, Tolerability, and Pharmacokinetics (PK) of Single and Multiple Ascending Oral Doses of iQ-007

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral iQ-007 in Healthy Male and Female Adult Participants

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: iQure Australia Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled study conducted in healthy adult volunteers to assess the safety, tolerability and pharmacokinetics of iQ-007. iQ-007 may be indicated for use in patients with Focal Seizures and Drug-resistant Epilepsy (DRE).

Detailed description

This is a randomized, double-blind, placebo-controlled study conducted in healthy adult volunteers. The study will be conducted in 2 parts: a single ascending dose (SAD) component and a multiple ascending dose (MAD) component. Part A (SAD) will involve the administration of a single oral dose of iQ-007 or placebo capsules on Day 1 in Cohorts Al, A2, A3, A5 and A6. Participants in Cohort A4, will be required to fast overnight (minimum of 8 hours) prior to eating a high fat breakfast 30 minutes prior to a single oral administration of iQ-007 or placebo capsules on Day 1. Part B (MAD) will involve the administration of multiple twice daily oral doses of iQ-007 or placebo capsules on Days 1 to 14 (total of 27 doses) in cohorts B1, B2, B3.

Conditions

• Drug Resistant Epilepsy
• Focal Seizure

Interventions

Type	Name	Description
DRUG	iQ-007	Highly selective, orally bioavailable, positive allosteric modulator (PAM) of the excitatory amino acid transporter-2 (EAAT2) and its rodent homologue (glutamate transporter-1\[GLT-1).
DRUG	Placebo	Oral capsules identical in appearance to drug and containing vehicle only (Gelucire/Capmul-M).

Timeline

• Start date: 2025-04-08
• Primary completion: 2026-01-29
• Completion: 2026-01-29
• First posted: 2025-03-27
• Last updated: 2025-12-29

Locations

1 site across 1 country: Australia